WO2003011373A1

WO2003011373A1 - Connection of housing sections of an administration device for dosed administration of a distributable product

Info

Publication number: WO2003011373A1
Application number: PCT/CH2002/000412
Authority: WO
Inventors: Fritz Kirchhofer; Roney Graf
Original assignee: Tecpharma Licensing Ag
Priority date: 2001-07-30
Filing date: 2002-07-22
Publication date: 2003-02-13
Also published as: AU2002317133B2; JP2004535904A; ES2271284T3; CN1543363A; PL205273B1; HU228256B1; PL366465A1; DE10163328B4; DE50210596D1; IL159664A0; MXPA04000864A; EP1416983B1; EP1416983A1; CA2451892C; US8545456B2; WO2003011374A1; AU2002317134B2; HUP0402426A2; HRP20040095A2; PL205976B1

Abstract

An administration device for dosed administration of a distributable product, said device comprising: a) a front housing section (1, 3) having a reservoir (2) for the product, b) a rear housing section (11), c) an output member (4) which is borne by at least one (1, 3) of the housing sections (1, 3, 11) for performing a distributing movement enabling a selected product dose to be distributed, d) a dose adjustment member (9; 39) performing a dosing movement for a selection of the product dose in relation to the output member (4), e) and a dosing and drive mechanism (12; 32) which can be displaced in a rotational and translatory manner about an axis of rotation (L) in relation to the front housing section (1, 3) and which can be coupled during connection of the housing sections (1;3;11) to the output member (4) and dosing adjustment member (9; 39) in such a way that a rotational movement of the dosing and drive device (12; 32) results in a dosing movement of the dose adjustment member (9; 39) and a translatory movement of the dosing and drive device (12; 32) results in a distributing movement of the output member (4).

Description

Connection of housing sections of an administration device for the metered administration of a dispensable product

In product administration devices with at least two housing sections, the invention relates to the connection of these two housing sections. Preferred examples of devices according to the invention are injection devices, in particular injection pens, particularly preferred examples are semi-disposable pens. The device can also form a dosing part of an inhalation device or a device for oral administration or another type of administration of a fluid product.

WO 97/17095 describes an injection device which consists of a metering and actuation module and a reservoir module which are detachably connected to one another. The reservoir module is designed as a disposable module, while the metering and actuation module is intended for reuse with a new reservoir module after the reservoir module has been used up. The reservoir module contains a reservoir for a product to be injected and supports a piston rod which acts on a piston accommodated in the reservoir for product distribution. The piston rod has an external thread which is in threaded engagement with an internal thread of a dose setting member. The piston rod is guided linearly, so that when the dose setting member rotates, the piston rod moves in one direction of advance towards the piston, thereby changing a clear distance between a front end of the piston rod and the piston. The dosing and actuation module and the reservoir module are connected to each other by screwing on or clicking on. An advantage of the concept of the semi-disposable injection device is that parts of the device involved in the metering and dispensing need only be designed for dispensing a single reservoir content. Since such parts would always have to be returned to an initial state when used repeatedly, they would also be exposed to a risk of damage that should not be underestimated. The safety of the correct dose selection and dose distribution must therefore not be less with semi-disposable injection devices than with fully reusable devices. In addition, the replacement of a complete reservoir module is easier than the replacement of only one reservoir.

However, the assembly of the dosing and actuation module with a new reservoir module can pose problems, particularly with regard to the correctness of the dose selection for the first product distribution to be carried out after the assembly. Because of the coupling of the piston rod, dose setting element and the metering and actuation module required for the purpose of metering and dispensing, there is a risk that the assembly of the position of the dose setting element or even the piston rod due to the assembly of the reservoir module and metering and actuation module in an unforeseeable manner being affected. The problem can occur with any dosing and dispensing mechanism in which the dosing and dispensing processes are carried out separately, as is the case with injection devices. The problem is also not limited to semi-disposable pens. Rather, the problem is afflicted with any administration device in which the coupling of the piston rod or another output member, dose setting member and a metering and drive device required for metering and dispensing is produced by simply connecting two housing sections. In addition, there is a desire, in particular in the case of self-administration of the product, for simplicity in handling, wherein simple handling not only increases handling convenience, but also increases safety. In an administration device with at least two housing sections and a metering and dispensing mechanism, the parts of which are coupled to one another by the assembly of the housing sections, it is an object of the invention to maintain a defined initial state of the metering and dispensing mechanism and the assembly by the assembly of these housing sections to simplify anyway.

The invention relates to the connection of a front housing section and a rear housing section in an administration device, preferably an injection device, which allows the administration of a product in a selectable dose or a plurality of selectable doses. The injection device accordingly comprises the front housing section and the rear housing section. The product is contained in a reservoir. The front housing section can form the reservoir directly, but more preferably a container accommodated by the front housing section, for example a commercially available ampoule, forms the reservoir.

The administration device further comprises an output member which is supported by at least one of the housing sections, preferably the front housing section, in such a way that it can carry out a dispensing movement by means of which a previously selected product dose is dispensed from the reservoir. Since the product is usually dispensed by moving a piston accommodated in the reservoir in a feed direction towards an outlet of the reservoir, a piston rod preferably forms the output element of a metering and dispensing mechanism of the administration device. The output member can be permanently, ie permanently, connected to the piston, which should also be understood to mean an integral design of the piston and output member. In a preferred embodiment, however, the piston and the driven member are designed as separate components and, for the purpose of product distribution, it presses the driven member with a front end against a rear of the piston. Furthermore, the administration device includes a dose setting element which serves to select the product dose and for this purpose carries out a dosing movement relative to the output element and preferably also to the front housing section. If the product is distributed by means of a piston and piston rod, the dosing movement of the dose setting element sets the maximum stroke of the piston rod for its discharge movement.

Finally, the injection device comprises a metering and drive device which is translatory relative to the front housing section and rotatable about an axis of rotation. The metering and drive device is connected to the rear housing section before the housing sections are assembled. The rear housing section can form a metering element of the metering and drive device by being in a connection end position which it assumes after assembly of the housing sections, i.e. after the connection has been made, is rotatable relative to the front housing section about a common longitudinal axis. Preferably, however, the rear housing section is fixed in the connection end position relative to the front housing section in a rotationally and preferably also not translationally, and accordingly does not assume a metering function. When establishing the connection between the front and the rear housing section, preferably directly by establishing the connection itself, the metering and drive device is coupled to the output element and the dose setting element in such a way that a rotational movement of the metering and drive device after the connection has been established the metering movement of the dose setting member and a translational movement of the metering and driving device causes the dispensing movement of the driven member.

The coupling of the output element, dose setting element and metering and drive device can be achieved by a direct pairwise engagement of two of these components without the interposition of transmission elements take place, as is preferred, without the interposition of one or more other transmission elements being thereby excluded. The dose setting member is preferably coupled to the driven member and at least one of the housing sections, preferably the front housing section, in such a way that it executes the dispensing movement only together with the driven member and is moved relative to the driven member against the feed direction by the rotational movement of the metering and drive device. A direct engagement with the output member is preferably a thread engagement.

The rotational movement of the dosing and drive device is preferably transmitted to a rotational movement of the dose setting member or of the driven member about the same axis of rotation in order to obtain the dosing movement of the dose setting member. In preferred embodiments, the dosing movement of the dose setting member can be a combined translation and rotation movement or a pure translation movement. The discharge movement of the driven member is preferably a translation movement in the same direction and particularly preferably along the same translation axis as the translation movement of the metering and drive device. The rotational movement of the metering and drive device is also referred to below as the metering movement and its translational movement is also referred to as the dispensing movement. The axis of rotation and the translation axis of the metering and drive device are particularly preferably identical. A translatory movement of the dosing member preferably also takes place along this axis.

In a preferred first embodiment, the metering and drive device is in an immediate, non-rotatable engagement with the driven member in order to first transfer the rotational movement for the purpose of dose selection to the driven member and via the driven member to the dose setting member, so that the dose setting member carries out its metering movement. In a particularly preferred second embodiment, the dosing and Drive device and the dose setting member directly in an anti-rotation engagement, ie in this case it makes the dose setting member with the rotational movement of the metering and drive device, so that its metering movement is composed of a rotational and a translational movement. In both embodiments, the driven element and the dose setting element are coupled, preferably directly in engagement with one another, in such a way that they execute the dispensing movement together.

According to the invention, at least one axial guide is formed on one of the housing sections and at least one engagement element is formed on the other of the housing sections. The at least one axial guide and the at least one engagement element engage in one another when the connection of the housing sections is established and preferably also after the connection has been established in order to form a linear guide for the housing sections. The linear guide ensures that the housing sections are pushed onto one another relative to one another with respect to the axis of rotation of the metering and drive device and preferably absolutely secured against rotation when establishing their connection. In addition to the movement of the sliding onto one another between the housing sections, no relative movement is preferably possible. The axially linear sliding of the housing sections makes the assembly of the device particularly easy. Furthermore, during the production of the coupling of the metering and drive device to the driven member and the dose setting member, undesired rotational movements, which could cause a metering movement of the dose setting member, are transmitted to the driven member and / or the dose setting member due to unintentional rotational movements of the housing sections be it only because of reaction movements of the metering and drive device to such unintentional rotational movements between the

Housing sections. If the front housing section and the rear housing section together form a locking device, this locking device preferably comprises a locking lock which allows the two housing sections to be locked to one another only in a front end position of the metering and drive device. In this case, the inventive axial guidance of the housing sections to one another provides a further advantage that the locking cannot be prevented by moving the dose setting member during the assembly by producing the coupling. The latter could namely have an influence on the front end position of the metering and drive device.

For the linear guidance of the housing sections, the at least one axial guidance is preferably directly on, i.e. formed in or on a lateral surface of one of the housing sections. The axial guide particularly preferably forms a guide channel for the at least one engagement member of the other of the housing sections. Preferably, the at least one engagement member in the guide channel is closely guided on both sides. The at least one engagement member is also preferably directly on, i.e. formed in or on a lateral surface of the other of the housing sections as an axially short engagement cam or as an axially elongated engagement rib.

It is advantageous if a plurality of axial guides are formed at a distance from one another in the circumferential direction on the lateral surface of one of the housing sections. The multiple axial guides are expediently arranged evenly distributed over the circumference of the lateral surface. The formation of a plurality of axial guides, in particular the formation of a plurality of axial guides arranged uniformly distributed over the circumference, facilitates the alignment of the housing sections, since the housing sections can be pushed onto one another in a plurality of predetermined rotational angle positions. For the sake of completeness, it should be pointed out that several engagement elements are also provided on the other of the housing sections can, in particular a plurality of engagement elements in a distribution that is also uniform over the circumference.

In order to facilitate the alignment of the two housing sections with respect to their angular position relative to one another, a guide channel formed by the at least one axial guide, which faces the other of the housing sections during the alignment, can end in a funnel-shaped widening. If two juxtaposed projecting sections, for example ribs, each form an axial guide with their mutually facing side walls, these projecting sections taper axially so as to form the funnel-shaped widening. It is also particularly advantageous if such protruding sections taper at their end, which faces the other of the housing sections, in the radial direction towards the lateral surface of their housing section. A combined axial and radial taper at the inlet of the axial guide, in particular in a guide channel, particularly facilitates the alignment of the housing sections. If several axial guides are provided on one of the housing sections, preferably several and particularly preferably all axial guides are axially and preferably also radially tapered.

The statements made above with regard to the one or more axial guides also apply to the at least one or more engagement elements of the other housing section.

If, prior to connecting the housing sections, the dose setting member is connected to the front housing section and the dosing and drive device is connected to the rear housing section, as is preferred, then the dose setting member and a dosing element or dosing and driving element of the dosing and drive device become their respective Housing section preferably held in predetermined rotational angle positions relative to the respective housing section. They are particularly preferably axially linearly guided by their housing section in the respective rotational angle position. The metering element or metering and drive element is held by the rear housing section in its discrete rotational angle positions by a releasable engagement, preferably a latching engagement. The intervention preferably also produces a clicking sound when the dosing element or dosing and drive element is moved from one angle of rotation position to the next during its dosing movement, so that the dosing process is also indicated acoustically.

The dose setting member can be linearly guided by the front housing section in a non-releasable guiding engagement. If the dosing movement of the dose setting member is a combined rotation and translation movement, the fixation in the predetermined rotational angle positions must of course be releasable. In this case, the engagement between the dose setting member and the front housing section is preferably also a latching engagement. The predetermined rotational angle positions of the dose setting member and the dosing element or dosing and drive elements are matched to the axial guidance of the housing sections, so that in each of the predetermined rotation angle positions of the dose setting member and the dosing element or dosing and drive elements when the housing sections are pushed axially onto one another, the coupling of the output member, Dose adjuster and dosing and drive device ve _. is produced without rotation.

The dosing and drive device can work manually, semi-automatically or fully automatically. In the first case, both the rotary metering movement and the translatory dispensing movement are carried out manually. In the second case, either the metering movement or the dispensing movement is carried out manually, and the other movement is effected by motor or by means of another type of force application, for example by means of spring force, if the user has triggered the corresponding movement by an actuating handle. In the third case, the fully automatic dosing and drive device, the dosing movement and the pouring movement motorized or by means of another force, for example spring force. In this case, only the dose is selected manually, for example by means of one or more buttons, and the dispensing movement is also triggered by the user's own corresponding actuating handle. In most versions, the administration device according to the invention is equipped with a manual metering and drive device, which is then referred to as a metering and actuating device. Insofar as there is talk of a metering and actuating device, the manual execution is referred to as this. Insofar as there is talk of a metering and drive device, this is not intended to impose any restriction with regard to manual, semi-automatic or fully automatic, but rather each of the embodiments should be included. However, the term “metering and actuation module” is used in connection with all designs of the metering and drive device.

The metering and drive device can have a metering element which carries out the metering movement and separately a drive element which carries out the dispensing movement. However, the metering movement and dispensing movement are preferably carried out by the same body of the metering and drive device, which is therefore also referred to below as a metering and drive element or as a metering and actuating element.

The product is preferably a fluid, particularly preferably a liquid, for medical, therapeutic, diagnostic, pharmaceutical or cosmetic use. The product can be, for example, insulin, a growth hormone or thin to viscous, mushy food. The administration device is preferably used in those uses in which a user administers the product himself, as is customary, for example, in diabetes therapy. The use in inpatient and outpatient areas by trained staff should not be excluded. In an injection device, the product can be administered by means of an injection cannula or, for example, a nozzle for needleless injections. The injection or infusion can in particular be carried out subcutaneously or venously, or also intramuscularly. In the case of administration by inhalation, the selected product dose can be poured out of the reservoir, for example, into a chamber of the inhalation device and atomized by means of an atomization device for inhalation. Oral administration or administration via the esophagus is also conceivable, to name just a few examples of the administration.

The administration device is particularly preferably semi-disposable. In this case, the front housing section is the carrier of a reservoir module that is disposed of after the reservoir has been emptied or is returned to a circuit, and the rear housing section is the carrier of a metering and actuation module that can be used repeatedly in connection with a new reservoir module. Since the reservoir module is also sold separately as a consumption module, it is also the subject of the invention separately. The metering and actuation module can also be the subject of the invention separately. A system of an administration device and at least one reservoir module, which can replace the reservoir module of the device according to consumption, likewise forms an object of the invention. The concept of the two-part administration device in a part intended for single use and a part intended for repeated use (semidisposable) is advantageous in particular for injection pens, but further also for, for example, inhalation devices or devices for the oral intake of a product or an artificial nutrition.

Further preferred embodiments of the invention are described in the subclaims, features which are only claimed in relation to the administration device or only in relation to a reservoir module or a metering and actuating module, and are also preferred features in relation to the other subject matter of the claim. Exemplary embodiments of the invention are described below with reference to figures. Features which become apparent from the exemplary embodiments advantageously form the subjects of the claims individually and in each combination of features. Features that are only disclosed in one example further develop the other example or show an alternative, provided nothing to the contrary is disclosed or can only be the case. Show it:

Figure 1 shows two parts of a reservoir module after a first

Exemplary embodiment, FIG. 2 shows the reservoir module obtained from the two parts of FIG. 1,

3 shows an injection device according to the first exemplary embodiment, comprising the reservoir module of FIG. 2, in a longitudinal section, FIG. 4 shows part of the injection device of FIG. 3,

FIG. 5 shows a mechanical holder of the reservoir module in a longitudinal section and two views, FIG. 6 shows a blocking device for one mounted by the mechanical holder

7 shows a piston rod in a longitudinal section and an end view,

8 shows a locking block in a longitudinal section, a view and a top view, FIG. 9 shows a second exemplary embodiment of an injection device,

10 shows the cross section AA of FIG. 9, FIG. 11 shows the cross section BB of FIG. 9, FIG. 12 shows the cross section CC of FIG. 9, FIG. 13 shows the cross section DD of FIG. 9, FIG. 14 shows the mechanism holder of the second exemplary embodiment in a perspective view, FIG. 15 14 the cross section AA of FIG. 15, FIG. 17 the dose setting member of the second exemplary embodiment in a perspective view, FIG. 18 the dose setting member of FIG. 17 in a longitudinal section, FIG. 19 the dose setting member of FIG. 17 in a view,

FIG. 20 shows the dose setting member of FIG. 17 in a top view,

21 shows a part of the injection device according to FIG. 3 and

FIG. 22 shows part of the injection device according to FIG. 9.

FIG. 1 shows a view of a reservoir part 1 and a mechanical holder 3, which are connected to one another to form the reservoir module 10 shown in FIG.

In FIGS. 1 and 2, a piston rod 4 can also be seen, which projects into the mechanical holder 3 at an end of the mechanical holder 3 facing away from the reservoir part 1 and from the mechanical holder 3 in a feed direction pointing in the longitudinal axis L of the piston rod 4 to a direction of the mechanical holder 3 facing away from the front end of the reservoir part 1 is slidably mounted. The reservoir part 1 is essentially a hollow cylinder with a circular cross section, which has at its front end a connection area for a connection to a needle holder for an injection needle. The reservoir part 1 serves to hold a reservoir container, which in the exemplary embodiment is formed by an ampoule 2 which can be seen in the longitudinal section in FIG. 3. An outlet at the front end of the ampoule 2 is closed in a fluid-tight manner by a membrane. When the needle holder is attached to the front end of the reservoir part 1, a rear part of the injection needle pierces the membrane, so that a fluid connection is established between the tip of the hollow injection needle and the reservoir 2.

Figure 3 shows the injection device in its entirety in a longitudinal section. In the ampoule 2, a piston is received so as to be displaceable in the feed direction towards the outlet formed at the front end of the ampoule 2. The displacement of the piston in the feed direction displaces product from the ampoule 2 and dispenses it through the outlet and the injection needle. The piston rod 4 feeds the piston rod, which presses with its front end against the piston and thereby moves the piston in the feed direction during its own feed. The piston rod 4 is held by the mechanical holder 3 such that it can be moved in the feed direction but not against the feed direction after overcoming a certain resistance. The backward movement of the piston rod 4 against the feed direction is prevented by a blocking device 8. The blocking device 8 is axially fixed by the mechanical holder 3, ie it is held in the mechanical holder 3 in such a way that it cannot be moved in and against the feed direction. However, it is supported by the mechanism holder 3 so as to be rotatable about the longitudinal axis L. The blocking device 8 also generates the resistance that must be overcome for the forward movement.

The blocking device 8 is shown in FIG. 6 alone. It is formed by a one-piece ring element which bears on the mechanism holder 3 between two mutually spaced shoulders 3b, which protrude radially inward from an inner jacket of the mechanism holder 3, about the longitudinal axis L. The shoulders 3b form a fixing device for the axial fixing of the blocking device 8. The mounting of the blocking device 8 in the mechanism holder 3 can best be seen from the illustration of the mechanism holder 3 in FIG. 5.

A dose setting element 9 is also accommodated in the mechanism holder 3. The dose setting member 9 is designed as a threaded nut and is in threaded engagement with an external thread of the piston rod 4. The dose setting member 9 is secured against rotation by the mechanical holder 3, but is guided so as to be axially linearly movable in and against the feed direction. The piston rod 4 and the dose setting member 9 form a spindle drive in order to select the product dose to be administered.

The ampoule holder 1 and the mechanical holder 3 are connected to one another in a rotationally and securely secured manner and together form the Reservoir module 10 of the injection device, this reservoir module 10 comprising the piston rod 4 held by the mechanical holder 3 by means of the blocking device 8 and the dose setting member 9. The ampoule holder 1 and the mechanical holder 3 together form a front housing section of the injection device. A rear housing section 11 is positively connected to this front housing section 1, 3. The rear housing section 11 forms the carrier of a metering and actuating element 12 and, together with the same and parts of a locking device and other parts, forms a metering and actuating module 30 of the injection device.

With the exception of the dose setting element 9, the piston rod 4 and the blocking device 8, a metering and actuating device comprises the other components for the selection of the product dose and the actuation of the injection device. In particular, it comprises the dosing and actuating element 12. Furthermore, the dosing and actuating device comprises a counting and display device 17 for counting and visual display of the selected product dose. Last but not least, the counting and display device 17 makes the metering and actuation module 30 a high-quality and therefore high-priced part of the injection device. While the comparatively inexpensive reservoir module 10 is designed as a one-way module, the metering and actuation module 30 is intended for repeated use with ever new reservoir modules 10.

For the selection of the product dose, ie for the dosing, the dosing and actuating element 12 is rotatably mounted about the longitudinal axis L and furthermore can be displaced in and against the feed direction along the longitudinal axis L by the rear housing section 11. The metering and actuating element 12 is hollow cylindrical and surrounds the piston rod 4 with a front section. A rear section of the metering and actuating element 12 projects beyond a rear end of the housing section 11. A rod-shaped metering driver 13 is pushed into the metering and actuating element 12 from behind against a shoulder of the metering and actuating element 12 projecting radially inwards. Furthermore, a closure 14 is located at the rear end Dosing driver 13 inserted into the dosing and actuating element 12. The metering driver 13 is axially fixed between the radially projecting shoulder of the metering and actuating element 12 and the closure 14 relative to the metering and actuating element 12. The metering driver 13 is also connected to the metering and actuating element 12 in a manner secured against rotation. The metering driver 13 projects into the hollow piston rod 4 from behind for the purpose of metering. The piston rod 4 has a connecting section 4a (FIG. 4) which engages with the metering driver 13 such that the piston stand 4 and the metering driver 13 and with it also the metering and actuating element 12 relative to one another about the common longitudinal axis L. cannot be rotated, but can be moved relative to one another along the longitudinal axis L in and against the feed direction. For this purpose, the connecting section 4a is designed as a linear guide for the metering driver 13.

A reset device 16 elastically tensions the dosing and actuating element 12 against the feed direction into the starting position shown in FIGS. 3 and 4. In the starting position, the metering and actuating element 12 can be metered about the longitudinal axis L. Subsequently, the selected product dose can be dispensed from the starting position by axially displacing the metering and actuating element 12. The resetting device 16 is formed by a spiral spring acting as a compression spring, which is received in an annular gap around the metering and actuating element 12 and between a radially inwardly projecting shoulder of the housing section 11 and an opposite, radially outwardly projecting shoulder of the metering and actuating element 12 is axially supported.

The blocking device 8 fulfills a double function. On the one hand, it ensures with its locking elements 8a that the piston rod 4 cannot be moved back against the feed direction relative to the mechanical holder 3 and thus in particular relative to the piston accommodated in the ampoule 2. In your Dual function, the blocking device 8 also prevents the piston rod 4 from moving forward as a brake during the metering process, in which the dose setting member 9 is moved axially toward the metering and actuating element 12 against the direction of advance.

In the starting position shown in FIGS. 3 and 4 before dosing, the dose setting member 9 lies in the feed direction against a stop against a dispensing stop 3c formed by the mechanical holder 3 (FIG. 5). The piston rod 4 is in permanent contact with the piston. For the purpose of metering, the dose setting member 9 is moved away from the dispensing stop 3c towards the metering and actuating element 12 by the threaded engagement with the piston rod 4 and the linear guide by the mechanical holder 3. As a result, a clear distance between a rear stop surface of the dose setting member 9 and a front stop surface of the metering and actuating element 12 is reduced, but on the other hand the clear distance between a front stop surface of the dose setting member 9 and the discharge stop 3c is increased. The latter distance between the discharge stop 3c and the dose setting member 9 is the path by which the dose setting member 9 is moved in the course of the pouring movement of the dosing and actuating element 12 and also the piston rod 4 is moved in the feed direction due to the thread engagement. The discharge stop 3c forms a front translation stop. During the dispensing movement, the piston rod 4 presses with its front end, which is formed by a plunger body which is connected to the piston rod 4 so that it cannot move in and against the feed direction, against the piston and presses the piston toward the outlet of the ampoule 2 in the feed direction. The longitudinal axis L forms the axis of rotation and translation of the movements which are carried out for the purpose of dosing and product distribution.

The distance that the dose setting element 9 and the dosing and actuating element 12 have between them before the dosing process, when the dose setting element 9 lies against the dispensing stop 3c, corresponds to the maximum product dose that can be selected and distributed in the course of a distribution. The stroke movement of the metering and actuating element 12 is of the same length with each distribution. Only the distance of the dose setting member 9 from the dispensing stop 3c and thus the path length that can be covered together in the course of the dispensing by the metering and actuating element 12 and the dose setting member 9 is set by the metering.

The braking function of the blocking device 8 and the brake engagement existing for this purpose between the piston rod 4 and the blocking device 8 are clear from the overview of FIGS. 6 and 7. On the one hand, the blocking device 8 for the braking intervention has two braking elements 8b, which, like the blocking elements 8a, are each formed by an elastically yielding catch. In the exemplary embodiment, the blocking device 8 is formed by a single ring element, from which four elastic snaps protrude axially on one end face. The catches are evenly distributed over the circumference of the ring element. Two mutually opposite snappers form the locking elements 8a and the two further snappers also arranged opposite one another form the braking elements 8b.

The piston rod 4 accordingly has two retraction locking devices 6, which are formed on the outer casing on opposite sides and extend in the longitudinal direction of the piston rod 4, and two feed braking devices 7 which also extend on the opposite sides in the longitudinal direction of the piston rod 4. The thread of the piston rod 4 for thread engagement with the dose setting member 9 is formed by four remaining threaded sections 5, which extend over almost the entire length of the piston rod 4. The retraction locking devices 6 and the feed braking devices 7 are each formed by a row of teeth. However, while the teeth of the retraction locking devices 6 are formed as saw teeth, which are swept in the feed direction, with locking surfaces pointing rearward and extending transversely to the feed direction, the two rows of teeth which have the Feed braking devices 7 do not form forward-facing locking surfaces with a comparable locking effect. The teeth of the feed braking devices 7 each have a softer tooth profile in comparison to the retraction locking devices 6. The braking intervention of the blocking device 8 with the feed braking devices 7 of the piston rod 4 is not intended to prevent a feed movement of the piston rod 4, but only to make it difficult to ensure that the piston rod 4 is not moved in the feed direction during metering. The teeth of the feed brake devices 7 are shaped on their front sides and the brake elements 8b are shaped on their rear sides, which touch the front sides of the teeth of the feed brake device 7, in such a way that a swelling force must be overcome in order to overcome the brake intervention, which force is not reached during metering. This threshold force is greater than the force required to move the teeth of the retraction locking devices 6 in the feed direction via the locking elements 8a. The threshold force is preferably at least twice the initial frictional force between the retraction locking devices 6 and the locking elements 8a. The frictional force between the latter also increases gradually only in the course of the feed movement between two successive locking interventions. The threshold force of the braking intervention, however, must be applied in each blocking intervention immediately at the beginning of the feed movement from one blocking intervention into the next one. However, the swelling force should not be so great that the user finds it disruptive when it is distributed.

An undesired advancing movement of the piston rod in response to the movement of the dose setting element 9 when selecting the dose can in principle also be brought about solely by the blocking engagement of the blocking device 8. However, such a movement is prevented more reliably because of the braking intervention than through the locking intervention alone.

The connection between the reservoir module 10 and the metering and actuation module 30 is positive. First, there is between the Mechanism holder 3 and the housing section 11 a locking engagement, which prevents a relative movement in the axial direction. In addition to the locking engagement, the front housing section 1, 3 and the rear housing section 11 are axially linearly guided directly against one another in order to prevent a relative rotation during the connection and in the connected state. The axial guides 3d of the mechanism holder 3, which form the linear guide with one or more corresponding engagement elements of the rear housing section 11, can be clearly seen in FIG. The axial guides 3d are formed by guide surfaces on guide ribs; they could also be formed by guide surfaces in axially extending recesses. In this way, axial guide channels are obtained. The guide ribs are axially tapered, so that insertion funnels leading into the guide channels are formed for the one or more engagement elements of the rear housing section 11. For even better centering of the housing sections 1, 3 and 11 at the start of the connection, the guide ribs are also tapered in the radial direction. The one or more engaging elements of the rear housing section 11 is or are preferably formed like the axial sections 3d on the mating surface, ie the inner surface, of the rear housing section 11.

The locking engagement is between a female,. first locking element 3a of the mechanism holder 3 (FIG. 5) and a locking ring 20 which is connected to the rear housing section 11 so as to be radially movable but not axially movable. The locking ring 20 forms a male, second locking element 21 which engages radially directly in the first locking element 3a. Between the first locking element 3a and the second locking element 21 there is a lock / bolt connection, the axial relative movements between the reservoir module 10 and the metering and actuation module 30 prevented.

Figures 3 and 4 show the locking element 21 in locking engagement with the locking element 3a. The locking element 3a is formed by an annular web and a groove, which on the outer jacket of the mechanism holder 3rd circulate. The ring land forms a rear side wall of the groove. The second locking element 21 is formed by a cam which protrudes radially inward from the inner jacket of the locking ring 20 and is pressed radially inward in the locking engagement by a restoring device 24 above an inner jacket surface of the rear housing section 11 and protrudes into the receiving locking element 3a. The locking ring 20 is supported in its entirety in the radial direction by means of the resetting device 24 on an inner circumferential surface formed by the housing section 11, so that the resetting device 24 presses approximately in a radial extension of the locking element 21 against the outer jacket of the locking ring 20. The locking ring 20 surrounds the mechanical holder 3 and, in its entirety, can be moved radially back and forth against the restoring force of the restoring device 24, so that the second locking element 21 can be brought into and out of locking engagement with the first locking element 3a. The rear housing section 11 forms a narrow sliding guide for the radial movement of the locking ring 20. On its side radially opposite the locking element 21, the locking ring 20 forms an unlocking button 22 for the user. For the radial guidance of the resetting device 24 designed as a compression spring, a guide cam projects radially from the outer lateral surface of the locking ring 20 facing away from the locking element 21.

In the circumferential direction on both sides of this guide cam and axially behind the guide cam protrude from the outer surface of the locking ring

20 furthermore two locking cams 23 which press radially outwards against a locking lock 25. Due to the abutment of the locking cams 23 against the locking lock 25, there is a radial movement of the locking element

21 prevented, which could lead to a release of the locking engagement. The locking engagement existing between the locking elements 3a and 21 is thus secured by the locking lock 25. This securing exists in every displacement position of the dosing and actuating element 12 with the exception of a release position which the dosing and actuating element 12 occupies at the end of its dispensing movement. The release position therefore coincides with the foremost displacement position which the dosing and actuating element 12 assumes when, in the course of its dispensing movement, it strikes the dose setting element 9 and the dose setting element 9 in turn against the dispensing stop 3c of the mechanism holder 3. As long as the metering and actuating module 30 is not yet connected to the reservoir module, a mechanical stop for the metering and actuating element 12 is formed by a stop element 31 of the metering and actuating device. In the exemplary embodiment, a reset holder ring, which serves to reset the display 17, forms the stop element 31. The stop of the metering and actuating element 12 against this stop element 31 defines the release position of the metering and actuating element 12 in this case, the one defined by the stop element 31 Release position corresponds to that which is defined by the abutment of the dose setting member 9 on the discharge stop 3c.

FIG. 8 shows the locking lock 25. In the exemplary embodiment, it is formed in one piece by a locking slide. The locking lock 25 has a plate-shaped main body which extends axially in the assembled state, as shown for example in FIG. 4. At one end, a web 26 protrudes from the main body at right angles. In the assembled state, the web 26 extends radially up to the metering and actuating element 12. The web 26 is used to fasten the locking lock 25 to the metering and actuating element 12, which for this purpose has two annular webs, axially spaced on an outer lateral surface, the drivers 15a and 15b form. The front driver 15b simultaneously forms the support shoulder for the resetting device 16. The locking lock 25 protrudes with its web 26 into the annular space formed between the drivers 15a and 15b and is tightly edged axially on both sides by the two drivers 15a and 15b.

At a front end facing away from the web 26, the main body of the locking lock 25 is provided with an axial recess 27 which leads to the front end of the locking lock 25 is open. In this way, axially extending locking tongues 28 are formed on both sides of the recess 27. The two locking cams 23 of the locking ring 20 are arranged such that one of these locking cams 23 presses against one of the locking tongues 28, as long as the dosing and actuating element 12 does not assume the release position. During the axial movement of the locking lock 25, the resetting device 24 for the locking element 21 extends through the axial recess 27.

In the main body of the locking lock 25, engagement recesses 29 are also formed, which define the release position of the metering and actuating element 12. One engagement recess 29 is provided for each locking cam 23. The position of the engagement recesses 29 is selected such that they only overlap with the locking cams 23 and thereby permit the locking cams 23 to be retracted when the metering and actuating element 12 has been advanced into its release position.

It is clear that in the arrangement specifically selected in the exemplary embodiment, a single locking cam 23 could also be provided and the locking lock 25 accordingly only one. could have only one recess 29 and possibly only one locking tongue 28. In principle, the locking lock could also be made in one piece with the metering and actuating element 12. However, the design as a separate part offers advantages with regard to the manufacture, the assembly and the interaction of the metering and actuating element 12 with the piston rod 4. With regard to the installation position of the locking lock 25, it should also be pointed out that the locking lock 25 is attached to the locking element 21 facing away from an inner surface of the housing 11 is supported. In this way, the stability of the lock for the locking engagement is increased. The housing 11 preferably forms an axial guide for the locking lock 25. The mode of operation of the injection device is described below, it being assumed that a new reservoir module 10 and a metering and actuation module 30 that has already been used at least once are assembled and a first product distribution is then carried out.

The metering and actuation module 30 and the new reservoir module 10 are aligned axially to one another so that their two longitudinal axes are aligned with one another. The reservoir module 10 is then inserted with its rear end into the housing 11 of the metering and actuation module 30 which is open towards the front.

Here, the housing section 1, 3 and the housing section 11 center on the tapered ends of the guide ribs 3d of the mechanism holder 3. During the sliding on, the two housing sections are axially guided linearly to one another in a rotational angle position predetermined by the linear guide until the housing sections 1, 3 and 11 are one Assume the final connection position in which the locking engagement of the locking elements 3a and 21 can be established or sets itself.

The dosing and actuating element 12 is locked in predetermined rotational angle positions relative to the rear housing section 11. The linear guidance of the housing sections 1, 3 and 11 and the rotational angle locking position of the metering and actuating element 12 are coordinated with one another in such a way that the non-rotatable engagement of the metering and actuating element 12 with the piston rod 4 in every locking position of the metering and actuating element 12 and in each rotational angle position in which the housing sections 1, 3 and 11 are linearly guided together.

If the dosing and actuating element 12 is in an axial position relative to the housing section 11, which lies behind the release position, the locking element 21 is in its radially innermost position by the locking lock 25 Position held. In this position of the locking element 21, the metering and actuation module 30 and the reservoir module 10 cannot be pushed onto one another up to the connection end position and therefore cannot be connected to one another, since the ring web formed on the outer casing of the mechanism holder 3, which also forms the first locking element 3a, counteracts beforehand the second locking element 21 comes to rest.

The ring land can be reduced to a short radial projection in the tangential direction if it is ensured that the housing sections 1, 3 and 11 can only be assembled in the rotational angle position in which such a projection and the second locking element 21 lie in axial alignment come. The ring land or radial projection could also form the first locking element 3a alone, since it is the essential function of the first locking element 3a to only allow the connection between the reservoir module 10 and the metering and actuating module 30 to be established when the metering and actuating element 12 is its Takes release position. If this condition is met, the dosing and actuating element 12 would ensure, when establishing the connection between the reservoir module 10 and the dosing and actuating module 30, that the dose setting element 9 is in its zero dosing position, in which it is at the discharge stop 3c of the mechanism holder 3 triggers.

In order to produce the condition fulfilling the condition explained above, the user presses the dosing and actuating element 12 axially relative to the rear housing section 11 into the release position. In this relative position between the housing section 11 and the metering and actuating element 12, the locking cams 23 can be moved into the engagement receptacles 29 of the locking lock 25. The user therefore not only presses the dosing and actuating element 12 into at least the release position, but at the same time also pushes the first locking element 20 out of the locking engagement by means of the unlocking button 22. The reservoir module 10 can now be moved axially over the ring web of the first locking element 3a and further inserted into the rear housing section 11. The user can release the release button 22. As soon as the first locking element 21 overlaps the second locking element 3a, it snaps into the receiving locking element 3a due to the force of the return device 24, so that the locking engagement is established. The reservoir module 10 and the metering and actuation module 30 are now connected to one another in a defined manner with respect to the position of the dose setting member 9 and the piston rod 4. If the dose setting member 9 was still a clear distance from the dispensing stop 3c before the locking engagement was made, this distance is eliminated due to the action of the metering and actuating element 12 required to establish the connection. An accompanying product release can be accepted and may even be desirable for the purpose of priming the injection needle. The counting and display device 17 is preferably zeroed.

In the defined initial state that is brought about in this way, the user can carry out the metering. The dosing is carried out by rotating the dosing and actuating element 12 about the longitudinal axis L and relative to the housing section 11. Since the dosing driver 13 is connected to the dosing and actuating element 12 in a rotationally secured manner and in turn engages in the piston rod 4 in a rotationally secured manner, the dosing and Actuating element 12 with the piston rod 4 during the rotary metering movement. Due to the thread engagement between the piston rod 4 and the dose setting member 9 and the linear guidance of the dose setting member 9 by the mechanical holder 3, the dose setting member 9 executes an axial translatory dosing movement in the direction of the dosing and actuating element 12, which is predetermined by the thread pitch of the mutual thread engagement. The dosing and actuating element 12 forms a rear translation stop 12c, which limits the translatory dosing movement of the dose setting member 9 and thereby defines the maximum adjustable discharge stroke. The counting and display device 17 counts the dose units corresponding to the angular position of the dosing and actuating element 12 and displays them optically.

After selecting the desired product dose, the dosing process is finished. The selected product dose is dispensed by means of the dispensing movement of the metering and actuating element 12 pointing in the direction of advance of the piston. In the course of its dispensing movement, the dosing and actuating element 12 abuts the dose setting member 9 and takes it with it. By pushing the dose setting element 9 against the discharge stop 3c of the mechanism holder 3 in the course of the dispensing movement, the dispensing movements of the metering and actuating element 12 and the product distribution are ended. After releasing the dosing and actuating element 12, this is preferably moved by the reset device 16 against the feed direction into a new starting position for a new dosing and product distribution. The counting and display device 17 is preferably coupled to the metering and actuating element 12 such that it has meanwhile been reset to zero. If necessary, it has means for counting and displaying the total amount of product already poured out and thus the remaining amount of product remaining in the ampoule 2.

In order to detach the reservoir module 10 from the metering and actuating module 30, the metering and actuating element 12 is moved into the release position, i.e. up to the stop against the dose setting member 9. In this position, the user can release the locking engagement again by pressing the unlocking button 22 and separate the reservoir module 10 from the metering and actuation module 30.

FIGS. 9 to 13 show a second exemplary embodiment of an injection device in a longitudinal section and four cross sections. The injection device of the second embodiment is the same as that of the first embodiment with respect to the locking and the locking lock 25 such that reference is made to the related description of the first embodiment. In particular, the locking lock 25 of the second exemplary embodiment is identical to that of the first exemplary embodiment with regard to all functional details. The same applies to the locking elements 3a and 21.

The locking ring 20 and the position of the locking cams 23 relative to the locking element 21 and relative to the locking lock 25 in the initial state of the device can be seen particularly well in the cross sections of FIGS. 10, 11 and 12, which are also representative of the first exemplary embodiment in this regard is referred.

The injection device of the second exemplary embodiment differs from the first exemplary embodiment in the intervention and the movement sequence of the components involved in the metering. In addition to the functions of the mechanism holder of the first exemplary embodiment, the mechanism holder in particular fulfills the function of positioning the dose setting element in discrete rotational angle positions which can be changed relative to the mechanism holder for the purpose of dosing. The blocking device of the second exemplary embodiment, on the other hand, is simpler than that of the first exemplary embodiment. In the following, only the differences compared to the first exemplary embodiment are described in the first place, whereby for components that have the same basic function as the components of the same name of the first exemplary embodiment, but differ in details, 30's numbers with the same final digit or exactly the same reference numerals, such as in the first embodiment. Insofar as no statements are made regarding the second exemplary embodiment, the corresponding statements regarding the first exemplary embodiment should apply.

In the second exemplary embodiment, this is axially linearly movable relative to the rear housing section 11 and about the longitudinal axis L. rotatable dosing and actuating element 32 connected to the dose setting member 39 secured against rotation. The dosing and actuating element 32 and the dose setting member 39 can be moved relative to one another and relative to the housing sections 1, 3 and 11 in and against the feed direction. The piston rod 4 is held against rotation by the mechanism holder 3. The retraction locking device 6, which has the same function as the first exemplary embodiment, in cooperation with locking elements of the blocking device 38, which is integrally formed on the mechanical holder 3, prevents movement of the piston rod 4 against the feed direction, but permits movement in the feed direction. The locking elements simultaneously form the retraction lock and the anti-rotation device for the piston rod 4. Furthermore, as in the first exemplary embodiment, the metering and actuating element 32 also forms a sliding guide for the piston rod 4.

When dosing, the dosing and actuating element 32 carries out the same rotary dosing movement as the dosing and actuating element 12 of the first exemplary embodiment. However, due to the non-rotating intervention, the dose setting member 39 is taken along during the rotary metering movement. The thread engagement between the piston rod 4 and the dose setting member 39 is again comparable to that of the first exemplary embodiment, so that a stop 39c formed by the dose setting member 39 due to the rotary metering movement and the thread engagement with the piston rod 4 in the course of the metering counter to the feed direction onto a front one End of the metering and actuating element 32 is moved. In contrast to the first exemplary embodiment, the dose setting member 39 thus performs a rotary metering movement and a translatory metering movement relative to the front housing section while the piston rod 4 is stationary. As a result of the dispensing movement of the metering and actuating element 32 after the metering has been completed, the piston rod 4 is advanced by the path length which corresponds to the clear distance between a stop surface of the stop set by the metering Dose setting member 39 and the discharge stop 3c of the mechanism holder 3 corresponds.

The translatory dosing movement of the dose setting member 39 is limited against the feed direction by a rear translation stop 11c, which the rear housing section 11 itself forms directly. In the second exemplary embodiment too, the longitudinal axis L forms the axis of rotation and translation of the components which are involved in the metering and product distribution.

As in the first exemplary embodiment, the front housing section 1, 3 forms a sliding guide for the dose setting member 39. To form the sliding guide, an inner lateral surface of the mechanism holder 3 and an outer lateral surface of the dose setting member 39 are in sliding contact with one another. The dosing and actuating element 32 is in engagement with an inner circumferential surface of the dose setting member 39 in order to form the non-rotating connection between the dose setting member 39 and the dosing and actuating element 32.

In the second exemplary embodiment, the piston rod 4 does not have its own braking device beyond the retraction locking device 6. The front sides of the saw teeth of the retraction locking device 6 rather also alone form the braking device. The piston rod 4 of the second embodiment can, however, be replaced by the piston rod of the first embodiment. Correspondingly, in this case, the mechanical holder 3 of the second exemplary embodiment would also form at least one brake element, preferably both brake elements of the first exemplary embodiment.

FIGS. 14 to 16 show the mechanical holder 3 of the second exemplary embodiment in a perspective illustration, a side view and in the cross section AA entered in the side view. The mechanism holder 3 is, as in the first embodiment, as a one-piece sleeve part executed, preferably as a plastic injection molded part. It has a bead 3e on the outer jacket of a front sleeve section. The front sleeve section is inserted into the reservoir part 1 and, by means of the bead 3e, at least for the user it is non-releasably locked to the reservoir part 1.

The locking element 3a is formed on a central sleeve section of the mechanism holder 3 as in the first embodiment.

A rear sleeve section, which adjoins the locking element 3a, forms a plurality of axial guides 3d on its outer circumference. The axial guides 3d are formed by guide ribs which protrude radially on the outer circumference of the rear sleeve section. More specifically, the axial guide is formed by the axially extending, straight side walls of these guide ribs, so that, as in the first exemplary embodiment, axial guide channels are obtained. The guide ribs protrude from the middle sleeve section like fingers to the rear end of the mechanism holder 3, where they run out axially tapered. The axial guide 3d serves to linearly guide the rear housing section 11 when the reservoir module 10 is connected to the metering and actuation module 30. As can be seen in FIG. 9 and best in FIG. 11, the inner casing surface of the rear housing section 11 projects in number accordingly and shape adapted engagement elements 11d radially inward. An engagement element 11d protrudes into each of the axial guides 3d and is linearly guided by the axial guide 3d when the front housing section 1, 3 and the rear housing section 11 are pushed into one another for connection. In this way, it is ensured that no relative rotation can take place between the front housing section 1, 3 and the rear housing section 11 if the connection between the dosing and actuating element 32 and the dose setting element 39 is secured against rotation during the connection.

Centering is achieved by the axially tapering of the guide ribs at their rear ends and the widening of the guide channels to form insertion funnels facilitated between the front housing section 1, 3 and the rear housing section 11 for the purpose of connection. The ends of the guide ribs also taper radially to the lateral surface of the mechanism holder 3, whereby the centering of the housing sections 1, 3 and 11 relative to one another in a rotational angle position predetermined by the axial guide 3d is made even easier.

Just as the front housing section 1, 3 and the rear housing section 11 are prevented from rotating relative to one another, the dose setting member 39 is also fixed with respect to its rotational angle position relative to the front housing section 1, 3, this fixing being releasable allow the rotational movement of the dose setting member 39 required for the dosing. Therefore, on the one hand to enable the dosing movement of the dose setting member 39, but on the other hand to prevent an undesired dosing movement by establishing the connection between the front housing section 1, 3 and the rear housing section 11, the dose setting member 39 is removed from the mechanism holder 3 by means of a releasable latching connection fixed in discrete angular positions.

FIGS. 17 to 20 show the dose setting element 39 in individual representations. For the formation of the latching connection, a plurality of latching receptacles 39g are formed on the outer circumferential surface of the dose setting member 39 distributed over the circumference in a regular division. Each of the locking receptacles 39g is formed by a straight, axially extending groove with a contour that is rounded in cross section.

The mechanism holder 3 is provided with two locking lugs 3g (FIGS. 15 and 16). The two locking lugs 3g protrude radially inwards from an inner circumferential surface of the mechanism holder 3 in the rear sleeve section of the mechanism holder 3. They are arranged diametrically opposite one another. The respective jacket area of the mechanism holder 3, on which one of the locking lugs 3g is formed, forms a spring element 3f which is elastically flexible in the radial direction. Due to the elastic resilience and the rounded shape of the locking lugs 3g in connection with the rounded profile of the locking receptacles 39g, the locking engagement of the locking lugs 3g in the opposite locking receptacles 39g can be released. Solubility is required for dose selection. On the other hand, the latching engagement is designed such that the rotational angle fixation of the dose setting member 39 is so stable that when the front housing section 1, 3 is connected to the rear housing section 11, no undesired metering movement of the dose setting member 39 can take place when the rotating coupling of the metering and actuating element 32 is produced with the dosing and actuating element 32. The latching connection between the mechanical holder 3 and the dose setting member 39 results in a tactile signal during the dosing as an advantageous side effect. In order to maintain the favorable elasticity of the spring element 3f, the rear sleeve section of the mechanism holder 3 is cut out in the relevant jacket area, so that the spring element 3f is obtained as a ring segment which extends in the circumferential direction and is exposed axially on both sides.

17, 18 and 20 also show axial guides 39d for the rotationally secure engagement of the dose setting member 39 with the dosing and actuating element 32. The dosing and actuating element 32 is provided with at least one engaging element in order to provide the axial linear guide, ie the anti-twist device, between the metering and actuating element 32 and the dose setting member 39. The axial guides 39d are again guide channels which are formed by a plurality of axially extending guide ribs. Each of the guide ribs tapers axially and radially at its rear end facing the metering and actuating element 32 in order to facilitate the centering between the metering and actuating element 32 and the dose setting member 39 during the production of the non-rotatable engagement. The same construction as for the axial linear guidance of the housing sections 1, 3 and 11 is thus used for the axial linear guidance of dose setting member 39 and dosing and actuating element 32. Finally, for the sake of completeness, reference is also made to the metering thread 39a and the discharge stop 39c of the dose setting member 39, which can best be seen in FIG.

Finally, two anti-rotation devices are provided for the dose setting element 39, which act in the two axial end positions of the dose setting element 39. In this regard, reference is also made to FIG. 22.

In order to prevent the piston rod 4 from being moved back in response to a rotary dosing movement of the dose setting member 39, twist stops 39h are formed at a front end of the dose setting member 39. In the front end position, which the dose setting member 39 takes up immediately after a product has been dispensed or before a dose has been selected, the rotation stops 39h engage with rotation counter-stops 3h which are integrally formed on the mechanism holder 3 (FIG. 16). The twist stops 39h project axially from a front end face of the dose setting member 39, and the twist counter stops 3h axially oppose the twist stops 39h from an axially facing end face of the mechanism holder 3, which forms the filler stop 3c. The engagement between the rotation stops 39h and the rotation counter-stops 3h is such that it allows a rotary metering movement in a direction of rotation, which causes a translatory metering movement of the dose setting member 39 directed away from the dispensing stop 3c, but in the front axial end position a rotary metering movement in the opposite direction of rotation prevented.

Furthermore, a further pair of twisting stops and twisting counter-stops are provided, which are shaped and interact in basically the same way as the stops 3h and 39h. This second pair of twist stops is, on the one hand, twist stops 39i, which project axially from a rear end face of the dose setting member 39, and secondly, twist counter stops 11i, which axially project from the facing end face of the rear translation stop 11c Dose setting element 39 protrudes, but cannot be seen in FIG. 9 due to its small dimensions. The rear twist stop pair 11 i / 39i in the rear end position prevents the piston rod 4 from being moved in the feed direction in response to a metering movement of the dose setting member directed against the stop face of the rear translation stop 11c.

The height, i.e. the axial length, all the rotation stops 3h, 39h, 11i and 39i is matched to the thread pitch of the engaged dosing threads of the piston rod 4 and the dose setting member 39. The rotational stops are so short axially that the rotary dosing movement is not hindered by which the dose setting member 39 is moved away from the respective translation stop 3c or 11c.

When assembling the components of the reservoir module 10, the dose setting member 39 is screwed onto the piston rod 4 into a predetermined axial position, as can be seen from FIG. Then the piston rod 4 with the screwed-on dose setting member 39 is inserted into the mechanism holder 3 from behind until its blocking device 38 comes into locking engagement with the retraction locking device 6 of the piston rod 4 and furthermore the non-rotatable engagement between the rotation stops 39h of the dose setting member 39 and the rotation counter-stops 3h of the mechanical holder 3 is made. Already during the introduction into the mechanism holder 3, the dose setting member 39 is axially linearly guided by the mechanism holder 3 in a rotational angle latching position by the latching engagement between the latching lugs 3g and the latching receptacles 39g until the dose setting member 39 abuts the dispensing stop 3c of the mechanism holder 3. In this front end position of the dose setting member 39 relative to the mechanical holder 3, the non-rotatable engagement between the twisting stops 3h and 39h has already been established.

In this state, the mechanical holder 3 and a reservoir part 1 that is already equipped with a reservoir are connected to one another. In a next step, the rear housing section 11 of the completely assembled metering and actuation module 30 is pushed onto the mechanical holder 3, the mechanical holder 3 and the rear housing section 11 being able to center with respect to one another due to the axial guides 3d and the engagement elements 11d of the rear housing section 11 the centering can be linearly guided against each other linearly due to the guide engagement. In the course of being pushed on, the dosing and actuating element 32 comes into non-rotating engagement with the dose setting member 39, with a certain centering being able to take place here first by a linear guide corresponding to the axial guides 3d and engaging elements 11d.

The metering and actuating element 32 is in discrete rotational angular locking positions with the rear housing section in a locking engagement and is in the locking engagement, i.e. in the respective angular locking position, guided axially linear. The rotation angle difference between two successive

Angle of rest positions corresponds to a dose unit. The linear guidance between the mechanical holder 3 and the rear housing section 11 on the one hand and the discrete rotational angle positions of the dose setting member 39 relative to the mechanical holder 3 (locking lugs 3g and locking receptacles 39g) and the rotational angle locking positions of the metering and actuating element 32 relative to the rear housing section 11 on the other hand are such Coordinated that a linear sliding of the two housing sections 1, 3 and 11 always takes place in such a rotational angle position that the dose setting member 39 and the dosing and actuating element 32 are aligned relative to one another for their rotationally secured engagement, so that during the connection of the reservoir module 10 with the dosing and actuation module 30 there is no relative rotation between the components involved in the dosing.

With regard to the further details of the assembly, in particular the manufacture of the locking engagement, and the functioning of the injection device after the second embodiment is referred to the description of the first embodiment.

The injection device according to the first exemplary embodiment can also be provided with anti-rotation devices which prevent undesirable reaction movements of the piston rod 4 in the two axial end positions of the dose setting element 9 of the first exemplary embodiment. FIG. 21 shows the two anti-rotation devices, which are shaped in the same way as the anti-rotation devices of the second exemplary embodiment. However, the anti-rotation stops formed on the housing sections 1, 3 and 11 in the second exemplary embodiment are formed on the one hand by the blocking device 8 and on the other hand by the metering and actuating element 12. Thus, on the end face of the blocking device 8, which faces the dose setting member 9 axially, a plurality of twist stops 8h are formed, which project axially onto the dose setting member 9. Since the blocking device 8 is axially immovably supported by the front housing section 1, 3 and is connected to the piston rod 4 in a manner secured against rotation, the front rotation stop pair 8h / 9h also provides a rotation lock for the rotary metering movement taking place between the piston rod 4 and the dose setting member 9. The second pair of twist stops is formed between the dose setting member 9 and the rear translation stop 12c. As in the second exemplary embodiment, a plurality of rotation stops 12i project axially from the end face of the translation stop 12c, which faces the dose setting member 9 axially, in the direction of the dose setting member 9. As in the second exemplary embodiment, the dose setting member 9 is provided on its rear side with twisting stops 9i which come into engagement with the twisting stops 12i in the rear axial end position of the dose setting member 9. In the rear axial end position of the dose setting element 9, only the rotary dosing movement which causes a translatory dosing movement of the dose setting element 9 in the feed direction is permitted by the rear twist stop pair 9i / 12i. Reference numerals:

1 reservoir part, ampoule holder

2 reservoir, ampoule

3 mechanism holders

3a first locking element

3b fixing device

3c distribution stop, translation stop

3d axial guidance

3rd bead

3f spring element

3g latch

3h rotation stop

4 piston rod

4a connecting section

5 thread section

6 retraction locking device, row of teeth

7 Feed brake device, row of teeth

8 blocking device

8a locking element

8b braking element

8h rotation stop

9 dose setting element

9h rotation stop

9i twist stop

10 reservoir module

11 rear housing section

11d engaging element

11 i Twist stop

12 dosing and actuating element

12i twist stop dosing slaving

Closure a carrier, ring web b carrier, ring web

Reset device

Counting and display device

-

locking ring

Second locking element

release button

locking cam

Reset device

lock lock

Driver, web

axial recess

locking tab

indentation recess

Dosing and actuation module

stop element

Dosing and actuating element -37 -

blocking device

Dose setting element a Dosing thread c Dispensing stop d Axial guide g Snap-in holder, axial guide h Twist stop i Twist stop

Claims

An administration device for the metered administration of a dispensable product, the device comprising: a) a front housing section (1, 3), which comprises a reservoir (2) for the product, b) a rear housing section (11), c) one of at least one (1, 3) of the housing sections (1, 3, 11) driven output member (4) for executing a dispensing movement, through which a selected product dose is dispensed, d) a dose setting member (9; 39), which is used for a selection of the product dose executes a dosing movement relative to the driven member (4), e) and a dosing and drive device (12; 32) which is rotatable relative to the front housing section (1, 3) about an axis of rotation (L) and translationally and in which Establishing a connection of the housing sections (1, 3, 11) with the driven member (4) and the dose setting member (9; 39) is coupled so that a rotational movement of the dosing and drive device (12; 32) the D Oosing movement of the dose setting member (9; 39) and a translational movement of the metering and drive device (12; 32) bring about the dispensing movement of the driven member (4), characterized in that f) at least one axial guide (1, 3) of the housing sections (1, 3, 11) ( 3d) and on the other (11) of the housing sections (1, 3, 11) at least one engagement element (11d) is formed which, when the housing sections (1, 3, 11) are connected, form an interlocking linear guide, so that the housing sections (1, 3, 11) relative to one another up to a connection end position about the axis of rotation (L) not be rotated on each other.

2. Administration device according to claim 1, characterized in that the at least one axial guide (3d) is formed on a lateral surface of one (1, 3) of the housing sections (1, 3, 11).

3. Administration device according to the preceding claim, characterized in that on the lateral surface of one (1, 3) of the housing sections (1, 3, 11) a plurality of axial guides (3d) spaced apart in the circumferential direction are formed.

4. Administration device according to one of the preceding claims, characterized in that the at least one engagement element (11d) is formed on a lateral surface of the other (11) of the housing sections (1, 3).

5. Administration device according to one of the preceding claims ,. characterized in that the at least one axial guide (3d) tapers at one end, which faces the other (11) of the housing sections (1, 3, 11), in the axial direction and preferably also in the radial direction, in order to align the housing sections (1, 3, 11).

6. Administration device according to one of the preceding claims, that the at least one engagement element (11d) at one end facing the one (1, 3) of the housing sections (1, 3, 11) in the axial direction and preferably also in the radial direction is tapered to facilitate alignment of the housing sections (1, 3, 11).

7. Administration device according to one of the preceding claims, characterized in that the housing sections (1, 3, 11) can be pushed onto one another in a single rotational angle position or in a plurality of discretely predetermined rotational angle positions.

8. Administration device according to the preceding claim, characterized in that the at least one axial guide (3d) guides the housing sections (1, 3, 11) axially linearly to one another in each of the plurality of predetermined rotational angle positions.

9. Administration device according to one of the two preceding claims, characterized in that the at least one axial guide (3d) and / or the at least one engagement element (11d) prevents the housing sections (1, 3, 11) in a different angular position than the only one or the several predetermined rotational angle positions can be pushed onto one another.

10. Administration device according to one of the preceding claims, characterized in that the dose setting member (9; 39) of one (1, 3) of the housing sections (1, 3, 11) is guided axially linear.

11. Administration device according to one of the preceding claims, characterized in that the dose setting member (39) in predetermined rotational angle positions with one (1, 3) of the housing sections (1, 3, 11) is in a releasable engagement and is preferably guided axially linearly in the engagement is, the engagement is preferably a latching engagement.

12. Administration device according to the preceding claim, characterized in that the releasable engagement is a locking engagement, wherein at least one locking lug (3g) and at least one locking receptacle (39g), one of which on the dose setting member (39) and the other on the one (1, 3) of the housing sections (1, 3; 11) is formed, are in the locking engagement with one another and can be moved out of the locking engagement against a restoring elastic force.

13. Administration device according to one of the preceding claims, characterized in that the dose setting member (39) has at least one stop (39h; 39i) which, in a metering position of the dose setting member (39) with one of the housing sections (1, 3, 11) in one Locking engagement is present, which prevents movement of the dose setting member (39), which could cause an axial reaction movement of the driven member (4).

14. Administration device according to one of the preceding claims, characterized in that the front housing section (1, 3) comprises a first locking element (3a) and the rear housing section (11) comprises a second locking element (21) and the locking elements (3a, 21) in Lock the housing sections (1, 3, 11) axially to one another in a locking engagement.

15. Administration device according to one of the preceding claims, characterized in that the dosing movement of the dose setting member (9; 39) is a translation movement pointing in the direction of the axis of rotation (L) of the dosing and drive device (12; 32).

16. Administration device according to one of the preceding claims, characterized in that a rotational movement which the output member (4) and the dose setting member (9; 39) perform relative to one another or together relative to at least one of the housing sections (1, 3, 11) Dosing movement of the dose setting member (9; 39) causes.

17. Administration device according to one of the preceding claims, characterized in that the driven member (4) and the dose setting member (9; 39) with each other in a threaded engagement pointing in the direction of the axis of rotation (L) of the metering and drive device (12; 32) Are the longitudinal axis of the thread.

18. Administration device according to one of the preceding claims, characterized in that a cannula of at most 30 gauge, preferably a 31 or 32 gauge cannula, or a cannula which has a combination of outer diameter and inner diameter not specified in ISO-9626, with an outer diameter an injection or infusion cannula of the administration device of at most 320 μm and a wall thickness that is as thin as possible.

19. Reservoir module for an administration device, preferably the administration device according to one of the preceding claims, the reservoir module (10) comprising: a) a front housing section (1, 3) of the administration device, which comprises a reservoir (2) for a dispensable product, b) a piston which is accommodated in the reservoir (2) so as to be movable in a feed direction towards an outlet of the reservoir (2) in order to dispense product, c) a dose setting element (9; 39) which extends from the front housing section (1, 3) is movably received in order to carry out a metering movement and a dispensing movement, d) and a piston rod (4) which is connected to the dose setting member (9; 39) and is held by the front housing section (1, 3) such that a movement of the Prevents the piston rod (4) against the feed direction and is not caused in the feed direction by the metering movement, e) wherein at least one axial guide (3d) or at least one engagement element is formed on a lateral surface of the front housing section (1, 3) for the formation of a linear guide, around the front housing section (1, 3) and a rear housing section of the administration device during manufacture a connection of the housing sections to one another in a connection end position secured against rotation.

20. Reservoir module according to the preceding claim, characterized in that the dose setting member (39) in predetermined rotational angle positions with the front housing section (1, 3) is in a releasable engagement and is preferably guided axially linearly in the engagement, the engagement being preferably a latching engagement ,

21. Reservoir module according to the preceding claim, characterized in that the releasable engagement is a latching engagement, wherein at least one latching lug (3g) and at least one latching seat (39g), one of which on the front housing section (1, 3) and the other is formed on the dose setting member (39), are in the latching engagement with one another and can be moved out of the latching engagement against a restoring elastic force.

22. Reservoir module according to one of the preceding claims, characterized in that the front housing section (1, 3) and the dose setting member (39) each have at least one stop (3h, 39h) and these stops (3h, 39h) in a front metering position of the Dose setting member (39) are engaged to prevent movement of the dose setting member (39), which could cause a reaction movement of the piston rod (4) against the feed direction.

23. Reservoir module according to one of the preceding claims, characterized in that the front housing section (1, 3) comprises a sleeve-shaped reservoir part (1) with the reservoir (2) and a sleeve-shaped mechanism holder (3), which are manufactured separately and preferably connected to one another are that a user cannot break the connection without being destroyed, the mechanical holder (3) holding the piston rod (4).

24. Reservoir module according to the preceding claim, characterized in that the mechanical holder (3) forms a discharge stop (3c) for the dose setting member (9; 39) to limit the pouring movement, and that the dose setting member (9; 39) by its dosing movement is moved away from the discharge stop (3c) counter to the feed direction.

25. Reservoir module according to one of the two preceding claims, characterized in that the mechanical holder (3) comprises a blocking device (8; 38) and the blocking device (8; 38) and the piston rod (4) are in a safety intervention that prevents the piston rod (4) can be returned to a position which it assumed before executing a movement directed in the feed direction, and that the safety intervention cannot be released.

26. Reservoir module according to one of the preceding claims, characterized in that the reservoir module (10) is a consumption module that an emptying of the reservoir (2) is provided for an exchange as a whole.

7. System of an administration device according to one of the preceding claims and at least one reservoir module according to one of the preceding claims, wherein the reservoir module is provided as an exchange module for a reservoir module (10) forming the administration device, which is also designed according to one of the preceding claims.